Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of the ReCor Medical Paradise System in Clinical Hypertension (RADIANCE-HTN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02649426
Recruitment Status : Recruiting
First Posted : January 7, 2016
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
ReCor Medical, Inc.

Tracking Information
First Submitted Date  ICMJE January 4, 2016
First Posted Date  ICMJE January 7, 2016
Last Update Posted Date April 3, 2019
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2016)
Mean reduction in average daytime ambulatory systolic BP [ Time Frame: from baseline to 2 months post procedure ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02649426 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2016)
  • Reduction in average 24-hr/night-time ambulatory systolic BP [ Time Frame: from baseline to 2 months post procedure ]
  • Reduction in average daytime/24-hr/night-time diastolic BP [ Time Frame: from baseline to 2 months post procedure ]
  • All-cause mortality [ Time Frame: from baseline to 36 months post-procedure ]
  • Hypertensive or hypotensive emergency resulting in hospitalization [ Time Frame: up to 36 months ]
  • Hospitalization for heart failure [ Time Frame: from baseline to 36 months post-procedure ]
  • Stroke, transient ischemic attack, cerebrovascular accident [ Time Frame: from baseline to 36 months post-procedure ]
  • Acute myocardial infarction [ Time Frame: from baseline to 36 months post-procedure ]
  • End stage renal disease [ Time Frame: from baseline to 36 months post-procedure ]
  • Renal artery or vascular complications requiring intervention [ Time Frame: from baseline to 36 months post-procedure ]
  • Significant embolic events resulting in end organ damage [ Time Frame: from baseline to 1 month and 36 months post-procedure ]
  • Procedure related pain lasting > 2 days [ Time Frame: from baseline to 1 month and 36 months post-procedure ]
  • Acute renal injury [ Time Frame: from baseline to 1 month and 36 months post-procedure ]
  • Significant (>50%) and severe (>75%) new onset renal stenosis [ Time Frame: from baseline to 6, 12, 24 and 36 months post-procedure ]
    as diagnosed by duplex ultrasound and confirmed by renal CTA/MRA or as diagnosed/confirmed by study defined renal CTA/MRA at 12 months
  • Major access site complications [ Time Frame: from baseline to 1 month and 36 months post-procedure ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the ReCor Medical Paradise System in Clinical Hypertension
Official Title  ICMJE The "RADIANCE-HTN" Study. A Study of the ReCor Medical Paradise System in Clinical Hypertension
Brief Summary RADIANCE-HTN is a randomized, double-blind, sham controlled, 2-cohort study (TRIO and SOLO) designed to demonstrate efficacy and document the safety of the Paradise Renal Denervation System in two distinct populations of hypertensive subjects.
Detailed Description Subjects with essential hypertension controlled on 1 or 2 antihypertensive medications or uncontrolled on 0-2 antihypertensive medications will be included in the RADIANCE Solo cohort while subjects with treatment resistant hypertension on a minimum of 3 antihypertensive medications will be included in the RADIANCE Trio cohort. Prior to randomization, subjects will be hypertensive in the absence of hypertension medication (SOLO) or despite the presence of a stabilized, single pill, triple, fixed dose antihypertensive medication regimen (TRIO).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Vascular Diseases
Intervention  ICMJE
  • Device: The Paradise® Renal Denervation Ultrasound System
    Randomization will occur following the diagnostic renal angiogram. Blinded patients randomized to treatment will receive the renal denervation procedure using the Paradise System to deliver ultrasound energy to thermally ablate and disrupt the renal sympathetic nerves while sparing the renal arterial wall.
    Other Name: renal denervation
  • Device: Sham Procedure
    Randomization will occur following the diagnostic renal angiogram. For blinded patients randomized to control, the diagnostic renal angiogram will be considered the sham procedure.
    Other Name: renal angiogram
Study Arms  ICMJE
  • Experimental: Ultrasound Renal Denervation
    Subjects in the TRIO or SOLO cohorts that are randomized to treatment, will receive renal denervation following a renal angiogram
    Intervention: Device: The Paradise® Renal Denervation Ultrasound System
  • Sham Comparator: Sham Procedure
    For subjects in TRIO or SOLO cohorts that randomize to the sham procedure, the diagnostic renal angiogram intervention will be considered the sham procedure.
    Intervention: Device: Sham Procedure
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 5, 2016)
292
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

TRIO and SOLO Inclusion Criteria:

  • Appropriately signed and dated informed consent
  • Age ≥18 and ≤75 years at time of consent
  • Documented history of essential hypertension
  • SOLO Cohort only: Either an average seated office BP < 180/110 mmHg at screening visit while on a stable regimen of 1 or 2 antihypertensive medications for at least 4 weeks prior to consent or an average seated office BP ≥ 140/90 mmHg <180/110 mmHg despite lifestyle measures on no antihypertensive medications
  • TRIO Cohort only: Average seated office BP ≥ 140/90 mmHg at screening visit while on a stable regimen of at least 3 antihypertensive medications of different classes including a diuretic for at least 4 weeks prior to consent
  • Documented daytime ABP ≥ 135/85 mmHg and < 170/105 mmHg after 4-week washout/run-in period (SOLO cohort) or after 4-week stabilization period (TRIO cohort)
  • Suitable renal anatomy compatible with the renal denervation procedure and documented by renal CTA or MRA of good quality performed within one year prior to consent (a CTA or MRA will be obtained in patients without a recent (≤1 year) renal imaging)
  • Able and willing to comply with all study procedures

Solo Exclusion Criteria:

  • Renal artery anatomy on either side, ineligible for treatment including:

    • Main renal artery diameter < 4 mm and > 8 mm
    • Main renal artery length < 25 mm
    • A single functioning kidney
    • Presence of abnormal kidney (or secreting adrenal) tumors
    • Renal artery with aneurysm
    • Pre-existing renal stent or history of renal artery angioplasty
    • Prior renal denervation procedure
    • Fibromuscular disease of the renal arteries
    • Presence of renal artery stenosis of any origin ≥ 30%
    • Accessory arteries with diameter ≥ 2mm <4 mm and > 8 mm*
  • Evidence of active infection within 7 days of procedure
  • Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter
  • Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma Hb1Ac ≥ 9.0%)
  • Documented history of chronic active inflammatory bowel disorders such as Chrohn's disease or ulcerative colitis
  • eGFR of <40 mL/min/1.73 m2 (by Modification of Diet in Renal Disease formula)
  • Brachial circumference ≥ 42 cm
  • Any history of cerebrovascular event (e.g. stroke, transient ischemic event, cerebrovascular accident)
  • Any history of severe cardiovascular event (myocardial infarction, CABG, acute heart failure requiring hospitalization (NYHA III-IV)
  • Documented confirmed episode(s) of stable or unstable angina
  • Documented repeat (>1) hospitalization for hypertensive crisis within the prior 12 months
  • Prescribed to any standard antihypertensive of cardiovascular medication (e.g. beta blockers) for other chronic conditions (e.g. ischemic heart disease) such that discontinuation might pose serious risk to health
  • Documented history of persistent or permanent atrial tachyarrhythmia
  • Active implantable medical device (e.g. ICD or CRT-D; neuromodulator/spinal stimulator; baroreflex stimulator)
  • Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
  • Primary pulmonary hypertension
  • Documented contraindication or allergy to contrast medium not amenable to treatment
  • Limited life expectancy of < 1 year at the discretion of the Investigator
  • Any known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or for any reason in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements or whose participation may result in data analysis confounders (e.g. night shift workers)
  • Pregnant, nursing or planning to become pregnant (negative pregnancy test required, documented within a maximum of 7 days prior to procedure for all women of child bearing potential. Documentation of effective contraception is also required for women of child bearing potential) Concurrent enrollment in any other investigational drug or device trial (participation in non-interventional Registries is acceptable)

TRIO Exclusion Criteria

  • Renal artery anatomy on either side, ineligible for treatment including:

    • Main renal artery diameter < 4 mm and > 8 mm
    • Main renal artery length < 25 mm
    • A single functioning kidney
    • Presence of abnormal kidney (or secreting adrenal) tumors
    • Renal artery with aneurysm
    • Pre-existing renal stent or history of renal artery angioplasty
    • Prior renal denervation procedure
    • Fibromuscular disease of the renal arteries
    • Presence of renal artery stenosis of any origin ≥ 30%
    • Accessory arteries with diameter ≥2 mm <4 mm and > 8 mm*
  • Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter
  • Evidence of active infection within 7 days of procedure
  • Secondary hypertension not including sleep apnea (documented through clinical work up within the 12 months prior to consent- see protocol body for details)
  • Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma Hb1Ac ≥ 9.0%)
  • Documented history of chronic active inflammatory bowel disorders such as Chrohn's disease or ulcerative colitis
  • eGFR of <40 mL/min/1.73 m2 (by Modification of Diet in Renal Disease formula)
  • Brachial circumference ≥ 42 cm
  • Any history of cerebrovascular event (e.g. stroke, transient ischemic event, cerebrovascular accident) within 3 months prior to consent
  • Any history of severe cardiovascular event (myocardial infarction, CABG, acute heart failure requiring hospitalization (NYHA III-IV) within 3 months prior to consent
  • Documented confirmed episode(s) of unstable angina within 3 months prior to consent
  • Documented intolerance or contraindication for any of the antihypertensive drugs prescribed as a requirement of the study protocol
  • Prescribed to any standard anti-hypertensive CV medication (other than beta blockers) for other chronic conditions (e.g. ischemic heart disease) such that discontinuation might pose serious risk to health
  • Documented history of persistent or permanent atrial tachyarrhythmia
  • Active implantable medical device (e.g. ICD or CRT-D; neuromodulator/spinal stimulator; baroreflex stimulator)
  • Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
  • Primary pulmonary hypertension
  • Documented contraindication or allergy to contrast medium not amenable to treatment
  • Limited life expectancy of < 1 year at the discretion of the Investigator
  • Any known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or for any reason in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements or whose participation may result in data analysis confounders (e.g. night shift workers)
  • Pregnant, nursing or planning to become pregnant (documented negative pregnancy test required documented within a maximum of 7 days prior to procedure for all women of child bearing potential. Documentation of effective contraception is also required for women of child bearing potential)
  • Concurrent enrollment in any other investigational drug or device trial (participation in non-interventional Registries is acceptable)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Helen Reeve-Stoffer, PhD +44 7947 748006 hreeve-stoffer@recormedical.com
Contact: Meital Horesh-Bar, BA +1 650 542-9785 mhoresh-bar@recormedical.com
Listed Location Countries  ICMJE Belgium,   France,   Germany,   Netherlands,   Poland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02649426
Other Study ID Numbers  ICMJE CLN 0777
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: to be determined
Responsible Party ReCor Medical, Inc.
Study Sponsor  ICMJE ReCor Medical, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michel Azizi, MD, PhD Hôpital Européen Georges-Pompidou
Principal Investigator: Ajay J Kirtane, M.D Columbia University
PRS Account ReCor Medical, Inc.
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP